Empty Sterile Container
This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD…
This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges).
1manufacturer
1catalogue number
7510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K833065 |
| Record published | 2015-09-24 |
| Record revised | 2023-07-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature |
| Packaging | Case of 48 |
| Sizes | Total volume 3 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5C4462 | Total Volume 3 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sharesource Connectivity Platform | Baxter Healthcare Corporation | 7 |
| Peritoneal Dialysis | Merit Medical Systems, Inc. | 6 |
| Liberty® | Fresenius Medical Care | 5 |
| VersiPD | Fresenius Medical Care | 4 |
| VersiPD | Fresenius USA, Inc. | 3 |
| Liberty® PDx | Fresenius Medical Care | 3 |
| Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2 |
| Premier | Fresenius Medical Care | 2 |
| Safe-Lock® | Fresenius Medical Care | 2 |
| HomeChoice APD System | Baxter Healthcare Corporation | 2 |
| LOW Recirculation Volume APD SET | Baxter Healthcare Corporation | 2 |
| Sharesource | Baxter Healthcare Corporation | 2 |
Showing 12 of 38. All products under System, Peritoneal, Automatic Delivery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201867 | 2020-11-19 |
| K102936 | 2011-03-30 |
| K053512 | 2006-02-16 |
| K012988 | 2001-12-05 |
| K935659 | 1994-07-07 |
| K923065 | 1994-03-04 |
| K884554 | 1989-01-31 |
Recalls
19 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-15 | Class II | Process control | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. | 339,936 devices | |
| 2023-02-22 | Class II | Process design | The electrical safety testing was not properly performed on the impacted devices and additional testing is required | 16 units | |
| 2022-04-21 | Class II | No Marketing Application | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. | 78 units | 2026-05-27 |
| 2021-06-30 | Class II | Under Investigation by firm | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of | 5101 units | 2024-04-10 |
| 2021-06-30 | Class II | Under Investigation by firm | Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of | 1 unit | 2024-04-10 |
| 2018-12-11 | Class II | Software design | Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy | 7,688 devices | 2021-02-12 |
| 2018-12-11 | Class II | Software design | Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy | 1,085 devices | 2021-02-12 |
| 2018-10-10 | Class II | Mixed-up of materials/components | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispo | 8640 eaches | 2020-07-22 |
| 2018-07-12 | Class II | Under Investigation by firm | There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket. | 5445 units | 2021-03-31 |
| 2017-07-05 | Class II | Use error | Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD | 15144 units | 2020-10-05 |
| 2017-07-05 | Class II | Use error | Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD | 23732 units | 2020-10-05 |
| 2016-12-16 | Class II | Device Design | Customer complaints received for the presence of leaks | 8640 eaches | 2017-08-24 |
| 2016-02-16 | Class II | Under Investigation by firm | Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specif | 10 units | 2016-12-23 |
| 2015-06-29 | Class III | Device Design | Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the functio | 29355 | 2017-01-24 |
| 2014-12-08 | Class II | Device Design | Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage. | 8,640 units | 2015-10-28 |
| 2014-10-21 | Class II | Nonconforming Material/Component | The keypad buttons on HomeChoice devices may be activated without the operator pressing them. | 200 | 2015-09-01 |
| 2014-10-06 | Class II | Labeling design | There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems. | 96,458 systems | 2016-03-28 |
| 2014-04-24 | Class II | Under Investigation by firm | System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger. | 55 units | 2017-07-21 |
| 2013-10-16 | Class II | Process design | The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause | 75 units (US) | 2017-07-21 |
| 2013-10-07 | Class II | Labeling design | In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mit | *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,60 | 2016-12-23 |
| 2002-12-23 | Not classified | Other | Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy | 2007-12-11 | |
| 2002-12-23 | Not classified | Other | Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy | 2007-12-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.